1. Outcomes of Sorafenib and Metronomic Capecitabine in Child-Pugh B patients with advanced hepatocellular carcinoma in the era of immunotherapy: A real-life comparison with best supportive care.
- Author
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Stefanini, B., Bucci, L., Santi, V., Reggidori, N., Lani, L., Granito, A., Pellizzaro, F., Cabibbo, G., Di Marco, M., Ghittoni, G., Campani, C., Svegliati-Baroni, G., Foschi, F.G., Giannini, E.G., Biasini, E., Saitta, C., Magalotti, D., Sangiovanni, A., Morisco, F., and Gasbarrini, A.
- Abstract
The efficacy of systemic therapy for unresectable advanced hepatocellular carcinoma (aHCC) has not been proven in patients with Child-Pugh (C-P) B cirrhosis. Nevertheless, in real-world these patients are treated with tyrosine-kinase inhibitors (TKIs) since their toxicity is similar to that observed in C-P A patients and, off-label, with Metronomic Capecitabine (MC) in patients not amenable to TKIs. This study aimed to compare Sorafenib and MC's outcomes versus best supportive care (BSC) in C-P B-HCC patients. Between 2008 and 2020, among 774 consecutive C-P B patients with aHCC not amenable/responding to locoregional treatments extracted from the ITA.LI.CA database, 410 underwent Sorafenib, 62 MC, and 302 BSC. The propensity score matching method was used to correct the baseline unbalanced prognostic factors, with a 1:1 allocation of Sorafenib vs BSC, MC vs BSC, and Sorafenib vs MC patients, and Kaplan-Meier method and Log-rank test were used to define overall survival (OS) and differences. in the unmatched population median OS (95% CI) was 9.9 (8.3-11.4) months in Sorafenib, 8.0 (0.4-15.7) months in MC, and 3.9 (3.1-4.8) months in BSC-treated patients (p<0.001 for Sorafenib vs BSC and for MC vs BSC; p=0.812 for Sorafenib vs MC). In Sorafenib vs BSC-matched patients (135 couples) median OS was 7.3 (4.8-9.7) vs 3.9 (2.6-5.2) months (p<0.001). Independent predictors of survival were ECOG-Performance Status >1 [HR: 1.61 (1.22-2.13)], tumour size [HR: 1.04 (1.01-1.07)] macrovascular invasion [HR: 1.48 (1.12-1.96)], AFP >400 ng/mL [HR: 1.52 (1.14-2.04)], treatment-naïve [HR: 1.54 (1.15-2.07)] and Sorafenib [HR: 0.51 (0.38-0.68)]. In MC vs BSC matched patients (40 couples) median OS was 9.0 (0.2-17.8) vs 3.0 (2.2-3.8) months (p<0.001). In Sorafenib vs MC-matched patients (55 couples) the median OS did not differ (p=0.283). C-P B patients with aHCC undergoing BSC have poor survival. Both Sorafenib and MC treatment improve their prognosis. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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